BR-S601MU (SURGICAL VIDEO RECORDER)
FDA 510(k) clearance K890119 · decided 1989-01-24
Clearance details
- K-number
- K890119
- Device name
- BR-S601MU (SURGICAL VIDEO RECORDER)
- Applicant
- Victor Co. of Japan, Ltd. C/O Jvc Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-01-11
- Decision date
- 1989-01-24
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- FWC
- Device class
- 1
- Regulation number
- 878.4160
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Elmwood Park, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LUXTEC VIDEOLUX 20/20 CAMERA HEADLIGHT SYSTEM (K864381) | Luxtec Corp. | 1986-12-09 |
| KY-M280U SURGICAL CAMERA (K854988) | Us Jvc Corp. | 1986-01-24 |
Recalls involving this device
No recalls on record reference this clearance.